German Patent Application DE 10110758A1 proposes replacing a defective control device of a medical device with a control device blank, and, when a trigger condition is present, transmitting at least some of the programs and data of the defective control device to the control device blank and storing it there. In addition, the following optional developments are mentioned: disclosing the control device blank as an authorized control device blank, so only authorized control device blanks can access programs and data which are present in the control device; storing the time of data transmission in the control device and/or control device blank; deactivation of the defective control device following conclusion of data transmission, so its transmitting part does not transmit the available programs and data again; deactivation of a receiving function of the control device blank with the result that the control device blank cannot operate as a blank again. German Patent Application DE 10110758A1 is incorporated herein by reference in its entirety.
This method has the drawback that the manufacturer is not put in a position to be able to determine whether a replacement part, which was installed in a medical device by an external company, is being used in the medical device for the first time (i.e. directly after it was supplied by the manufacturer) or whether it has been disassembled from a different (for example from a withdrawn) medical device. Replacement parts which are installed in a housing, can be provided with a seal. Since companies (in-house and external), who are authorized by the manufacturer, have to open the housing for certain servicing or repair work, a damaged device seal could only prove a non-original state of the device component if all authorized servicing companies were equipped with devices seals for re-sealing. Distribution of device seals among authorized servicing companies cannot always be carried out for organizational reasons, or is undesirable.
The exemplary embodiments of the present disclosure will be described with reference to the accompanying drawings.